Phacotrabeculectomy With Collagen Matrix Implant (Ologen®... | NCT03506542

Studies
Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C

NCT03506542

Sponsor

Medical University of Lublin

Status

Completed

Last Update Posted

Apr 25, 2018Actual

Enrollment

53Actual

Phase

Phase 2

Conditions

Glaucoma
Cataract
Wound Heal

Interventions

Ologen
Phacotrabeculectomy
Mitomycin C

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jun 2, 2014Actual

Primary Completion Date

Mar 1, 2016Actual

Completion Date

Mar 30, 2017Actual

First Submitted Date

Apr 14, 2018

First Submission Date that Met QC Criteria

Apr 14, 2018

First Posted Date

Apr 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2018

Last Update Posted Date

Apr 25, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Aleksandra Wlaz, PhD, ophthalmologist in Department of Diagnostics and Microsurgery of Glaucoma, Medical University of LublinPrincipal Investigator

Lead Sponsor

Medical University of LublinOTHER

Collaborators

Name	Class
Aeon Astron Europe B.V.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study objective: To assess the efficacy and safety of collagen matrix implant (Ologen®; OLO) in phacotrabeculectomy and to compare with mitomycin C (MMC) augmented phacotrabeculectomy.
Study Design: The study is designed as a prospective randomized trial. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study.
Follow-Up: This investigation is including 7 post-operative visits and follow-up within 12 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 30, 90, 180, 270 and 360.

Detailed Description

Prospective randomized comparative study
Patients with cataract and:

primary open angle glaucoma (POAG) pseudoexfoliation (PEX) glaucoma (PEXG)

Phacotrabeculectomy augmented with OLO or MMC
Follow-up - 12 months

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ologen (OLO)	Experimental	Ologen implant (model 830601) placed over scleral flap during phacotrabeculectomy	Device: Ologen Procedure: Phacotrabeculectomy
Mitomycin C (MMC)	Active Comparator	Mitomycin C (MMC) 0.3 mg/ml for 3 minutes under the scleral flap during phacotrabeculectomy (standard procedure)	Procedure: Phacotrabeculectomy Drug: Mitomycin C

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ologen	Device	Ologen implant placed over scleral flap during the surgery to avoid usage of Mitomycin C	Ologen (OLO)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean intraocular pressure (IOP) after the surgery	Decrease in IOP before and after the surgery	12 months

Secondary Outcomes

Measure	Description	Time Frame
Mean best corrected visual acuity (BCVA) (LogMAR)	Increase in best corrected visual acuity (BCVA) (LogMAR) before and after the surgery	12 months
Evaluation of the filtering bleb in MBGS (Moorfields Bleb Grading System)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cataract
Primary open angle glaucoma or pseudoexfoliation glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication

Exclusion Criteria:

Difficulty in reading or speaking Polish
Previous ocular surgery
Pregnant and breastfeeding women
Angle closure glaucoma
Secondary glaucoma except pseudoexfoliation glaucoma
Ocular diseases with excessive scarring
Allergy to collagen or Mitomycin C

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tomasz Żarnowski, MD PhD Prof	Ophthalmology Clinic, Medical University in Lublin, Poland	Study Chair

Locations

Not provided

Type	Date	Date Unknown
Release	Oct 26, 2023
Reset	Nov 13, 2023

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 26, 2023			Nov 13, 2023

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma
D002386	Cataract

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases
D007905	Lens Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative
D016685	Mitomycin

Ancestor Terms

ID	Term
D008937	Mitomycins
D045563	Indolequinones
D011809	Quinones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided